BEUDAMED
    FDA Enforcement Class II Terminated

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    Recall: Z-1030-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1030-2013
    Event ID
    64665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra Burlington MA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    April 1, 2013
    Termination Date
    February 25, 2014
    Address
    22 Terry Ave, N/A, Burlington, MA, 01803-2516, United States

    Description

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    Reason

    If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.

    Code Info

    Serial Number Range: 1010 through 1380

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.

    Quantity

    371 units